- The Food and Drug Administration announced Wednesday an “innovation challenge" aimed at encouraging the development of medical devices such as digital health applications and diagnostic tests aimed at detecting, treating and preventing opioid addiction.
- The agency is accepting proposals between June and September from developers with products at any stage of development, or with an existing product attempting to show an improved risk profile compared to opioids for pain management.
- FDA’s device center will choose which applicants are accepted into the program in November. Those selected will have “enhanced interactions with FDA review divisions” during the development of their products, and FDA will grant the Breakthrough Device designation to products that meet the statutory criteria without requiring a separate application.
FDA expects that the products that go through the program will ultimately submit “one or more formal applications” for approval through its various device approval pathways.
“The FDA stands ready to provide significant assistance and expedite premarket review of applications to help bring innovative devices that, if properly instituted, could help those at risk for addiction or treat those who might develop opioid use disorder,” FDA device chief Jeff Shuren said in a statement.
The agency plugged the opportunity to work closely with the agency as an incentive for developers to create products that address the opioid crisis. Examples of desirable products include diagnostics that can identify those at high risk of addiction, treatments for pain that could replace opioids, treatments that could help alleviate opioid withdrawal symptoms and technologies that prevent illicit diversion of prescription opioids.
The innovation challenge builds upon HHS’ efforts to address the opioid crisis by encouraging the development of novel pain treatments, an element of its Five-point Strategy to Combat the Opioid Crisis.
The Centers for Disease Control and Prevention said in March that drug overdoses killed 63,632 Americans in 2016, with 66% of those deaths attributable to a prescription or illicit opioid. The surgeon general has said more Americans should carry around naloxone, which can reverse the effects of an opioid overdose.
As the opioid epidemic continues to take its devastating toll across the country, providers and payers have developed policies aimed at curbing misuse of the drugs. Prescribers are being asked to consider alternative pain management treatments and to check prescription drug monitoring programs. Some organizations are using data analyses to pinpoint patients who may be at high risk of opioid addiction in an attempt to stop a disorder before it starts.
“We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, that can contribute in novel and effective ways to help reduce the scope of this crisis,” FDA Commissioner Scott Gottlieb said in a statement.
Also, both chambers of Congress are in the process of moving sizable packages of opioid bills aimed at further tackling the crisis. Cowen Washington Research Group predicts a package is likely to pass Congress before the August recess.